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Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis
NCT06315738 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.
Conditions Studied
Interventions
- BIOLOGICAL ST266
Study Locations (7)
Florida
- Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies — Orlando
- BayCare Health System-St. Joseph's Women's Hospital — Tampa
Connecticut
- Yale-New Haven Hospital — New Haven
Illinois
- NorthShore University-Evanston Hospital — Evanston
North Carolina
- Duke University Medical Center (DUMC) — Durham
Oklahoma
- Oklahoma Children's Hospital — Oklahoma City
Pennsylvania
- University of Pittsburgh Medical Center Magee Womens Hospital — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2029-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06315738
The ClinicalTrials.gov registry entry for NCT06315738 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noveome Biotherapeutics, formerly Stemnion, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 1 intervention — of which ST266 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06315738 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, Connecticut, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06315738 about?
NCT06315738 is a clinical study titled "Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis". The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (...
What is the current status of trial NCT06315738?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-08-19. Estimated completion is 2029-11.
What conditions does trial NCT06315738 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06315738?
The interventions under investigation include: ST266 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06315738?
This trial is sponsored by Noveome Biotherapeutics, formerly Stemnion, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06315738 being conducted?
This trial has 7 study locations across Connecticut, Florida, Illinois, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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